- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners, such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... **Job title:** Clinical Research Director in Immunology & Inflammation (Rheumatology)...Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of… more
- Amgen (Washington, DC)
- …valued partner within the inflammation community. This role will report to the Director , Advocacy Relations, Inflammation , and will be based in the US, with ... world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety… more
- Gilead Sciences, Inc. (Foster City, CA)
- …, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Associate Director , CMC Regulatory Affairs for Biologics is responsible ... approval process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Responsible for development of regulatory… more
- Amgen (Thousand Oaks, CA)
- …and transform the lives of patients while transforming your career. **Executive Medical Director , US Medical Affairs Lead** **Live** **What you will do** Let's ... the world. In this vital role as Executive Medical Director , US Medical Affairs Lead, you will...processes, including but not limited to, clinical operations, commercial, regulatory , and medical affairs They will also… more
- Amgen (Washington, DC)
- …Join us and transform the lives of patients while transforming your career. ** Director , Corporate Affairs , Global Media Relations** **What you will do** Let's ... a company spokesperson and media strategist on the global relations team. The Director , Corporate Affairs , Enterprise Media Relations will be responsible for… more
- Lilly (San Diego, CA)
- …test therapeutic hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs , operations, and other stakeholders to optimize ... Translational Medicine, Clinical Pharmacology, Quantitative Systems Pharmacology, Clinical Operations, Regulatory Affairs , and Search and Evaluation/Business Development… more
- Amgen (Washington, DC)
- …investigators, and functions conducting the studies. + Collaborate with Medical Affairs , Clinical Development, Clinical Operations, Regulatory , Safety, Strategic ... inflammation . + Deep understanding of clinical trial operations, regulatory requirements, and digital health technologies. + Proven experience implementing… more
- Amgen (Washington, DC)
- …world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each ... transform the lives of patients while transforming your career. Clinical Research Medical Director , Uplizna **What you will do** Let's do this. Let's change the… more
- Amgen (Washington, DC)
- …world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each ... the lives of patients while transforming your career. **Clinical Research Medical Sr. Director - Thoracic Oncology** **What you will do** Let's do this. Let's change… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... could be critical in helping our teams accelerate progress. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible… more
- Sanofi Group (Morristown, NJ)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing. + ... helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for… more
- Amgen (Washington, DC)
- …world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each ... the lives of patients while transforming your career. **Executive Medical Director , Cardiovascular-Kidney-Metabolic (CKM)** **Live** **What you will do** Let's do… more
- BeOne Medicines (Emeryville, CA)
- …development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs , and Clinical Development to ensure robust study ... **General Description:** The Director of Biostatistics will provide strategic statistical leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies across… more
- Amgen (South San Francisco, CA)
- …Partner with Discovery Research, Clinical Pharmacology, Toxicology, Early Development, and Regulatory Affairs teams to ensure seamless progression from ... world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each… more
- Amgen (Chicago, IL)
- …world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each ... In this role, you will report into the TLL Director for TEPEZZA and will be part of the...interactions with KOLs are on-label and consistent with commercial, regulatory , and legal guidelines + Coverage of Midwest Region… more
- Amgen (Washington, DC)
- …world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation , General Medicine, and Rare Disease- we reach millions of patients each ... you will do** Let's do this. Let's change the world! Reporting to the HEOR Director , the HEOR Senior Manager is accountable for executing on the HEOR Book of Work,… more